ERIVEDGE Drug Patent Profile

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When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-three patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

DrugPatentWatch^® Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ERIVEDGE

International Patents:	53
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	44
Patent Applications:	2,046
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ERIVEDGE
What excipients (inactive ingredients) are in ERIVEDGE?	ERIVEDGE excipients list
DailyMed Link:	ERIVEDGE at DailyMed

Drug patent expirations by year for ERIVEDGE

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ERIVEDGE

Generic Entry Date for ERIVEDGE^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing NDA: 203388 Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 2
Oregon Health and Science University	Phase 2
Ulrik Lassen	Phase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ERIVEDGE

L01XJ	Hedgehog pathway inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ERIVEDGE

ERIVEDGE is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERIVEDGE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ERIVEDGE

Pyridyl inhibitors of hedgehog signalling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyridyl inhibitors of hedgehog signalling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for ERIVEDGE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602 Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ERIVEDGE

When does loss-of-exclusivity occur for ERIVEDGE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05282722
Estimated Expiration: See Plans and Pricing

Patent: 11201229
Estimated Expiration: See Plans and Pricing

Patent: 13219216
Estimated Expiration: See Plans and Pricing

Patent: 16203958
Estimated Expiration: See Plans and Pricing

Patent: 17261491
Estimated Expiration: See Plans and Pricing

Patent: 19226273
Estimated Expiration: See Plans and Pricing

Patent: 21205133
Estimated Expiration: See Plans and Pricing

Austria

Patent: 2768
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0514841
Estimated Expiration: See Plans and Pricing

Canada

Patent: 79002
Estimated Expiration: See Plans and Pricing

China

Patent: 1072755
Estimated Expiration: See Plans and Pricing

Patent: 2964294
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12630
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 89390
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7262
Estimated Expiration: See Plans and Pricing

Patent: 0700538
Estimated Expiration: See Plans and Pricing

Patent: 1100604
Estimated Expiration: See Plans and Pricing

Patent: 1890903
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 89390
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 300068
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1673
Estimated Expiration: See Plans and Pricing

Patent: 4451
Estimated Expiration: See Plans and Pricing

Japan

Patent: 43558
Estimated Expiration: See Plans and Pricing

Patent: 08511675
Estimated Expiration: See Plans and Pricing

Patent: 12184255
Estimated Expiration: See Plans and Pricing

Patent: 14148537
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 278
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07002584
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9385
Estimated Expiration: See Plans and Pricing

Norway

Patent: 9260
Estimated Expiration: See Plans and Pricing

Patent: 071719
Estimated Expiration: See Plans and Pricing

Poland

Patent: 89390
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 89390
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 89390
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0702537
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1225018
Estimated Expiration: See Plans and Pricing

Patent: 1366414
Estimated Expiration: See Plans and Pricing

Patent: 070085243
Estimated Expiration: See Plans and Pricing

Patent: 120139846
Estimated Expiration: See Plans and Pricing

Patent: 130083488
Estimated Expiration: See Plans and Pricing

Patent: 140048343
Estimated Expiration: See Plans and Pricing

Patent: 150002863
Estimated Expiration: See Plans and Pricing

Patent: 150090263
Estimated Expiration: See Plans and Pricing

Patent: 160058972
Estimated Expiration: See Plans and Pricing

Patent: 170001725
Estimated Expiration: See Plans and Pricing

Patent: 180122750
Estimated Expiration: See Plans and Pricing

Patent: 190072678
Estimated Expiration: See Plans and Pricing

Patent: 200019263
Estimated Expiration: See Plans and Pricing

Patent: 200118909
Estimated Expiration: See Plans and Pricing

Patent: 210090744
Estimated Expiration: See Plans and Pricing

Spain

Patent: 77430
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 565
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ERIVEDGE around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2011201229	Pyridyl Inhibitors of Hedgehog Signalling	See Plans and Pricing
Norway	20071719		See Plans and Pricing
New Zealand	589385	Pyridyl Inhibitors of Hedgehog Signalling	See Plans and Pricing
Mexico	2007002584	INHIBIDORES DE PIRIDILO DE SENALIZACION DE HEDGEHOG. (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING.)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ERIVEDGE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	CA 2013 00050	Denmark	See Plans and Pricing	PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
1789390	C01789390/01	Switzerland	See Plans and Pricing	PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: SWISSMEDIC 62497 30.05.2013
1789390	1390057-6	Sweden	See Plans and Pricing	PERIOD OF VALIDITY (FROM - UNTIL): 2025-09-03 - 2028-07-16
1789390	SPC/GB13/060	United Kingdom	See Plans and Pricing	PRODUCT NAME: VISMODEGIB OPTIONALLY IN THE FORM OF A SALT OR SOLVATE; REGISTERED: CH IKS-NO.62497 20130530; UK EU/1/13/848-EMEA/H/C 20130712
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description